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Title | Besponsa (inotuzumab ozogamicin) FDA Drug Label | ||||||||||||
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URL | https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761040 | ||||||||||||
Abstract Text |
Molecular Profile | Treatment Approach |
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Gene Name | Source | Synonyms | Protein Domains | Gene Description | Gene Role |
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Therapy Name | Drugs | Efficacy Evidence | Clinical Trials |
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Inotuzumab ozogamicin | Inotuzumab ozogamicin | 0 | 15 |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
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Inotuzumab ozogamicin | Besponsa | CMC-544|InO | CD22 Immune Cell Therapy 15 | Besponsa (inotuzumab ozogamicin) consists of calecheamicin covalently linked to anti-CD22 antibody, which delivers calecheamicin into CD22-positive cells, potentially leading to DNA damage and apoptosis (PMID: 24389139). Besponsa (inotuzumab ozogamicin) is FDA-approved for use in adult and pediatric patients 1 year and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (FDA.gov). |
Gene | Variant | Impact | Protein Effect | Variant Description | Associated with drug Resistance |
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Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
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